CRA Annex III important products — Class I and Class II explained

Classify by the product’s main functionality and the actual Annex III/IV category, using the technical descriptions in Implementing Regulation 2025/2392. A generic IoT label, an embedded firewall component or a medical wearable description does not settle CRA class or scope.

Conformity assessment A, B+C and H

Annex VIII offers internal control (A), EU-type examination plus conformity to type (B+C), and full quality assurance (H). Standard products may use A. Important Class I A depends on Article 32(2) full coverage through applicable harmonised standards, common specifications or qualifying certification; otherwise B+C or H. Class II uses B+C or H under Article 32(3). Article 32(5) allows qualifying important free/open-source software with public technical documentation to use A. Critical products require assessment of Article 8 certification conditions; absent the mandated suitable scheme conditions, Article 32(4) provides B+C or H. Classify the main product function against Annexes III/IV and implementing technical descriptions 2025/2392, not a component name alone.

Scope and exclusions

CRA concerns products with digital elements made available on the EU market whose intended or foreseeable use includes a direct or indirect logical or physical data connection. MDR/IVDR devices and other Article 2 exclusions require separate scope assessment. Assess manufacturer responsibility and the statutory remote-data-processing definition, not cloud dependence alone. Main product requirements apply from 11 December 2027; Article 14 reporting applies from 11 September 2026.

Evidence to keep with the product

Record the intended purpose, responsible economic operator, target market, first placing date and exact hardware/firmware configuration. For each applicable requirement, link the actual test or assessment record, dated standard/specification, scope and reviewer decision. Proposed controls and supplier marketing statements are not evidence that the final configuration has passed an assessment.

Separate an open question from a completed assessment. A report outside the laboratory's relevant scope, a different firmware build or an unverified exemption needs a reasoned decision before it supports a declaration. Keep original evidence and the issued declaration alongside any AI-assisted working draft.

Using Cenitia for this work

Cenitia assists with a limited regulatory catalogue and draft documents. The manufacturer must confirm applicability, actual applied specifications and completed assessment procedures. AI scores are quality signals, not a probability of conformity. Source monitoring raises a review prompt when validated source text changes; it does not automatically verify amendments, update the corpus or monitor every national rule and OJ standard edition. Public QR verification records issuance, not product certification.

Review status

This guide was substantively corrected by Cenitia on 2 October 2026 using the primary references below. It is an editorial summary, not an authoritative legal quotation or an independently signed expert opinion. Product-specific and licensed-standard questions remain subject to a real technical review.

Primary references

• Primary source 1